Events

Recall of MRSA Agar

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by BIOMERIEUX.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2005-07-20
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dmdiv-gelose-mrsa-id-biomerieux
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    On July 18, 2005, the company bioMérieux has withdrawn batches 795418401, 795204401, 794959301, 794783401, 794530501 from the in vitro diagnostic medical device called MRSA Agar ID reference 43451. This decision follows the possible decrease of the activity of the selective mixture used in the composition of this product. This decreased activity results in methicillin-sensitive Staphylococcus aureus strains exhibiting the growth and staining characteristics of methicillin-resistant Staphylococcus aureus. This device is a chromogenic culture medium for the detection and identification of methicillin-resistant Staphylococcus aureus (MRSA) from human specimens. The company has directly notified the recipients of the offending lots by means of the message. hereby validated (18/07/2005) (148 ko) by the Afssaps .. The competent European authorities concerned are informed directly by the manufacturer .. This information is intended for laboratory managers, the directors of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

MRSA Agar
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX